CFDA Measures on Foods for Special Medical Purposes Take Effect
The China Food and Drug Administration's (CFDA) Administrative Measures for Registration of Formulated Foods for Special Medical Purposes ("FSMP Measures") will enter into force on July 1, 2016.[1] The Measures define "foods for special medical purposes" (FSMP) to include food specially processed and prepared for people with eating restrictions, digestion and absorption disorders, metabolic disorders, or a particular disease to meet their special dietary or nutritional needs.[2] The Measures now require that domestic and overseas manufacturers intending to market FSMP in China register with CFDA. Domestic producers must file for registration before applying for their FSMP production permits.
By way of background, the 2015 amendment to China's Food Safety Law[3] designated FSMP as "special foods" subject to strict supervision and registration.[4] Whether a given product is regulated as an FSMP depends on a variety of factors, including product labeling and claims. Despite the existence of a number of National Standards relating to FSMP production and labeling, no registration and management framework for such products had been established.[5] Consistent with the Food Safety Law, the FSMP Measures now provide detailed registration guidance for FSMP producers and clarify CFDA's management and supervision rules.
The FSMP Measures primarily distinguish two primary classifications: (1) FSMP for infants between the ages of 0 and 12 months and (2) FSMP for people over one year of age. With regard to the latter, the Measures further define the following sub-categories:
- Formulated foods with full nutrition (capable of serving as the sole nutrition source);
- Formulated foods with special full nutrition (capable of serving as the sole nutrition source for a particular disease or medical condition); and
- Formulated foods with partial nutrition (which only meet partial nutritional needs).
On April 15, CFDA published five draft supplementary documents detailing registration and management requirements for public comments.[6] These documents address the following aspects of the registration system:
- Registration procedures and required application materials
- Requirements for product stability studies
- Requirements on clinical trials
- Specifications for labeling and instructions for use
- Checklist and decision criteria for field inspections of manufacturing sites
With regard to the clinical trial reports, these are only required for the registration of "FSMP with special full nutrition."[7] Clinical trials must be carried out in accordance with Quality Management Code for Clinical Test of Formulated Foods for Special Medical Purposes and conducted at medical institutes certified by CFDA.[8] In this regard, CFDA is expected to release both a quality management code and a list of qualified medical institutes.
Notably, companies exporting FSMP products into China are subject to field inspections as well as sampling at overseas manufacturing facilities where deemed necessary.
Official Launch of Registration Filing System
Between July 12th and 14th, CFDA announced the launching of the FSMP online application system,[9] and finalized the above-mentioned supplementary documents (with the exception of the requirements on clinical trials).[10] Accordingly, interested industry members now can register with the online application system and prepare the relevant application dossier in accordance with the FSMP Measures and its supplementary documents. Industry should move quickly to prepare and submit registration dossiers to ensure the compliance of FSMP products marketed in China.
Transition Period
Shortly before the July 1 effective date, CFDA issued Notice No. 119 (2016) indicating that, before January 1, 2018, FSMP products approved for manufacture in or export to China may continue to be sold up until the end of the product’s shelf life.[11] However, beginning on that date, FSMP products manufactured in China or exported to China must obtain a registration certificate.
The language used in the transition period announcement raises an interesting question. That is, CFDA has never officially “approved” any FSMP products, so which types of products are subject to the 18-month grace period? Informal communications with CFDA suggest that this refers to products that were previously approved as drugs and sold after the drug registration process was complete. This is supported by language used in CFDA’s official interpretation of the FSMP Measures,[12] which, when discussing the historical background, states that “in the late 1980s, FSMP began to enter the China market in the form of enteral nutrition preparations to serve clinical needs. They have been regulated as drugs and sold upon drug registration.” Thus, it appears that the 18 month grace period for “approved FSMP products” applies to a very limited scope of product (e.g., nutrition preparations that have successfully gone through the drug registration process). All other “unapproved FSMP” products, as discussed above, are immediately subject to the new FSMP registration process and should proceed with these filings immediately.
In the meantime, if you have any questions regarding FSMP registration, please do not hesitate to contact Keller and Heckman's Shanghai Representative Office or your contact at Keller and Heckman LLP.
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[1] See Administrative Measures for Registration of Formulated Foods for Special Medical Purposes, available at http://www.sda.gov.cn/WS01/CL0053/146741.html
[2] See Article 48 of the FSMP Measures.
[3] See P.R.C. Food Safety Law, available in Chinese at http://www.sda.gov.cn/WS01/CL0784/118041.html
[4] See Food Safety Law Articles 74 and 80. Article 80 requires that FSMP be registered with CFDA and registration materials, including the product formulation and details relating to production process, product safety and clinical effects, be provided upon application.
[5] See, for example, GB25596-2010, GB 29922-2013, and GB 29923-2013.
[6] Available at http://www.sda.gov.cn/WS01/CL0782/150540.html ; the comment period has been closed on May 15, 2016.
[7] This term is defined in Article 50 of the FSMP Measures to include FSMP that are capable of serving as the sole nutrition source to meet the nutritional demands of a target population with a particular disease or under special medical conditions (e.g., FSMP for diabetes, respiratory diseases, protein allergies, etc.).
[8] See Articles 29 and 30 of the FSMP Measures.
[9] The online system is available at http://lt1.zybh.gov.cn/qiye/login/loginAction!login.dhtml
[10] Available at http://www.sda.gov.cn/WS01/CL0087/159121.html
[11] Available at http://www.sda.gov.cn/WS01/CL0087/157260.html
[12] Available at http://www.sfda.gov.cn/WS01/CL1786/146743.html